AzTrials
AzTrials

EndometriosisNCT05812937

Intraoperative Intraabdominal Ultrasound for Endometriosis

An observational study of Endometriosis and Endometriosis; Bowel, run by University of Palermo at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The diagnosis of bowel endometriosis lesions is in most cases a combination of anamnesis, clinical exam, transvaginal ultrasound (and/or MRI and/or endorectal sonography) and laparoscopy. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Intraabdominal ultrasound
Type of treatment
Surgery or procedure
How many people
70 participants
Where
1 siteGermany
Study dates
1 Jan 2022to 1 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women affected by deep bowel endometriosis undergoing intraabdominal ultrasound.

Who may be able to join

  • All the patients with suspicion of endometriosis who undergo surgery.

Who cannot join

  • Patients under 18 years old;
  • Patients who didn't sign the informed consent.

Trial locations and contacts

1 site in 1 country.

Andrea Etrusco, M.D. contact

+39 388 1614022

etruscoandrea@gmail.com

Germany1 site, 1 recruiting
  • Albertinen Hospital

    Hamburg, 22457

    Andrea Etrusco, M.D., +39 388 1614022, etruscoandrea@gmail.com

    Recruiting

Other trials in Germany

About this study

Official title: The Diagnostic Value of the Intraoperative Intraabdominal Ultrasound for Deep Bowel Endometriosis

The diagnosis of bowel endometriosis lesions is in most cases a combination of anamnesis, clinical exam, transvaginal ultrasound (and/or MRI and/or endorectal sonography) and laparoscopy.

Both the transvaginal ultrasound as well as the MRI have showed a great accuracy with very good sensititivity and specificity regarding the imaging diagnosis of bowel endometriosis.

Read more

The conventional laparoscopy contributes to the diagnosis of bowel endometriosis by visualizing the nodules and palpating the deep endometriosis nodule using the instruments, therefor offering the surgeon a haptic feedback by grasping, pushing and rolling the bowel wall and the nodules. Horace Roman and Dan Martin showed that 25% of patients undergoing a conventional laparoscopic segmental bowel resection with a minilaparotomy hat palpable non-visualized endometriosis nodules. These nodules could be directly palpated with the hands because the bowel was exteriorized through the minilaparotomy. The direct palpation of the bowel offers of course a superior haptic feedback compared to the haptic feedback offered by the laparoscopic palpation using the instruments. However this was a direct palpation of only the oral part of the bowel. The aboral part of the bowel caudal to the staple line could not be evaluated by direct palpation. New surgical techniques for the segmental bowel resection with transvaginal/transanal NOSE(natural orifice specimen extraction) have been described in the last years. The novel techniques avoid the minilaparotomy and assure a 100% minimal invasive approach offering better esthetic outcomes.

However in such cases a direct palpation of the bowel wall using the hands in order to identify non- visualizable nodules is not possible as the bowel remains the whole time of the procedure inside of the abdomen. On the other side the robotic-assisted laparoscopy doesn't offer the surgeon a haptic feedback at all. In these cases the surgeon has to rely on the visual aspects of the lesions and therefor "touch" the lesions with his eyes - the visual information should replace the haptic feedback. So in the case of a robotic assisted laparoscopic segemental bowel resection with a NOSE it is not possible to palpate the bowel at all - neither with instruments, not with the hands. Other surgical techniques used to excise smaller colorectal nodules are the rectal shaving and the full thickness excision (disc excision) using a circular stapler. In these situations the surgeon has to rely exclusively on the visual information as well on the haptic feedback given by the conventional laparoscopic instruments. In more than 30% of the cases of full thickness rectal resection the resection the margins are infiltrated by the endometriosis nodules. All the above mentioned situations raise the question of the radicallity in terms of healthy resection margins and of multifocal lesions that cannot be visualized and/or palpated. In this study we are evaluating the diagnostic value of the intraoperative intraabdominal ultrasound for deep infiltrating colorectal endometriosis.

Being tested
Intraabdominal ultrasound
Keywords
Endometriosis, Deep bowel endometriosis, Ultrasound, laparoscopy
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraabdominal ultrasoundProcedure or surgery

    Also called Laparoscopic visualization, Laparoscopic palpation, Direct palpation in case of a conventional segmental bowel resection with specimen extraction per minilaparotomy.

    To assess the diagnostic value of the intraoperative intrabaabdominal ultrasound (IIUS) for endometriosis patients as well as the predictive potential of changing the therapeutic strategy during the surgery based on the ultrasound findings.

Study groups in NCT05812937
Study groupRoleWhat they receive
Women with suspicion of deep bowel endometriosisWomen with suspicion of deep bowel endometriosis undergoing intraoperative ultrasound to assess its diagnostic value for endometriosis patients as well as the predictive potential of changing the therapeutic strategy during the surgery based on the ultrasound findings.
Receives: Procedure: Intraabdominal ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of IIUS compared to TVS regarding the colorectal endometriosis

    Compare the dimmensions of preop. TVS-diagnosed nodules with the intraop. IUS dimensions.

    Measured: At the moment of the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2023
  2. Study start1 Jan 2022
  3. Primary completion1 Jan 2023
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05812937
Sponsor's protocol ID
INTA-US-ENDO
Status last verified
Mar 2023
First submitted
31 Mar 2023
Last updated
14 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis and Endometriosis; Bowel, run by University of Palermo at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Etrusco, M.D. (+39 388 1614022, etruscoandrea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of IIUS compared to TVS regarding the colorectal endometriosis (time frame: At the moment of the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in